Sign up to receive free email alerts when patent applications with chosen keywords are publishedSIGN UP

Abstract:

Methods and systems for providing data communication in medical systems
are disclosed.

Claims:

1. A computer implemented method for communicating rolling data in an
analyte monitoring system, comprising: retrieving with one or more
processors a first data type from a storage device, wherein the first
data type includes analyte sensor data obtained from an analyte sensor
positioned in fluid contact with an interstitial fluid under a skin
layer; retrieving with the one or more processors a predetermined portion
of a rolling data from the storage device, each predetermined portion of
the rolling data assigned a transmission time slot and includes one or
more of the following parameters: operational mode data, analyte sensor
slope data, temperature related data, power supply status data, data
transmission count data, or analyte sensor scaling factor data;
transmitting during a first transmission time slot a first data packet
including the first data type and the predetermined portion of the
rolling data assigned to the first transmission time slot to a remote
location; and transmitting during a second transmission time slot a
second data packet to the remote location subsequent to the first data
packet transmission, the second data packet including the first data type
and the predetermined portion of the rolling data assigned to a second
transmission time slot for transmission to the remote location; wherein
each transmitted data packet comprises the first data type and the
predetermined portion of the rolling data.

2. The method of claim 1 wherein the first data type is associated with
urgent data, and further, wherein the rolling data is associated with
non-urgent data.

3. The method of claim 1 wherein the analyte data includes real time
analyte data associated with the monitored analyte level.

4. The method of claim 3 wherein the analyte includes glucose, and
further, wherein the first data type is related to glucose level
information, and the rolling data is related to a predetermined scaling
factor associated with the glucose level information.

5. The method of claim 1 wherein each of the first and second data
packets include a transmit time count which is incremented by an integer
value with each subsequent transmission.

6. The method of claim 1 wherein the first data type includes current
sensor data and historic sensor data.

7. The method of claim 39 wherein the first data type in the first data
packet is current sensor data and the first data type in the second data
packet is historic sensor data.

8. The method of claim 40 wherein the historic sensor data includes
sensor data that immediately precedes the current sensor data.

9. An apparatus, comprising: one or more processors; and a memory storing
instructions which, when executed by the one or more processors, causes
the one or more processors to retrieve s a first data type from a storage
device, wherein the first data type includes analyte sensor data obtained
from an analyte sensor positioned in fluid contact with an interstitial
fluid under a skin layer, to retrieve a predetermined portion of a
rolling data from the storage device, each predetermined portion of the
rolling data assigned a transmission time slot and includes one or more
of operational mode data, analyte sensor slope data, temperature related
data, power supply status data, data transmission count data, or analyte
sensor scaling factor data, to transmit during a first transmission time
slot a first data packet including the first data type and the
predetermined portion of the rolling data assigned to the first
transmission time slot to a remote location, and to transmit during a
second transmission time slot a second data packet to the remote location
subsequent to the first data packet transmission, the second data packet
including the first data type and the predetermined portion of the
rolling data assigned to a second transmission time slot for transmission
to the remote location, wherein each transmitted data packet comprises
the first data type and the predetermined portion of the rolling data.

10. The apparatus of claim 9 wherein the first data type is associated
with urgent data, and further, wherein the rolling data is associated
with non-urgent data.

11. The apparatus of claim 9 wherein the analyte data includes real time
analyte data associated with the monitored analyte level.

12. The apparatus of claim 11 wherein the analyte includes glucose, and
further, wherein the first data type is related to glucose level
information, and the rolling data is related to a predetermined scaling
factor associated with the glucose level information.

13. The apparatus of claim 9 wherein each of the first and second data
packets include a transmit time count which is incremented by an integer
value with each subsequent transmission.

14. The apparatus of claim 9 wherein the first data type includes current
sensor data and historic sensor data.

15. The apparatus of claim 14 wherein the first data type in the first
data packet is current sensor data and the first data type in the second
data packet is historic sensor data.

16. The apparatus of claim 15 wherein the historic sensor data includes
sensor data that immediately precedes the current sensor data.

17. An apparatus, comprising: one or more processors; and a memory
storing instructions which, when executed by the one or more processors,
causes the one or more processors to retrieve s a first data type from a
storage device, wherein the first data type includes analyte sensor data
obtained from an analyte sensor positioned in fluid contact with an
interstitial fluid under a skin layer, to retrieve a predetermined
portion of a rolling data from the storage device, each predetermined
portion of the rolling data assigned a transmission time slot and
includes one or more of operational mode data, analyte sensor slope data,
temperature related data, power supply status data, data transmission
count data, or analyte sensor scaling factor data, to transmit during a
first transmission time slot a first data packet including the first data
type and the predetermined portion of the rolling data assigned to the
first transmission time slot to a remote location, to transmit during a
second transmission time slot a second data packet to the remote location
subsequent to the first data packet transmission, the second data packet
including the first data type and the predetermined portion of the
rolling data assigned to a second transmission time slot for transmission
to the remote location, and to increment a counter value indicative of a
power supply status of the apparatus, wherein each transmitted data
packet comprises the first data type and the predetermined portion of the
rolling data.

18. The apparatus of claim 17 wherein the first data type is associated
with urgent data, and further, wherein the rolling data is associated
with non-urgent data.

19. The apparatus of claim 17 wherein the first data type includes
current sensor data and historic sensor data.

20. The apparatus of claim 19 wherein the first data type in the first
data packet is current sensor data and the first data type in the second
data packet is historic sensor data.

Description:

RELATED APPLICATION

[0001] The present application is a continuation of U.S. patent
application Ser. No. 11/681,133 filed Mar. 1, 2007 entitled "Method and
Apparatus for Providing Rolling Data in Communication Systems," the
disclosure of which is incorporated herein by reference for all purposes.

BACKGROUND

[0002] Analyte, e.g., glucose monitoring systems including continuous and
discrete monitoring systems generally include a small, lightweight
battery powered and microprocessor controlled system which is configured
to detect signals proportional to the corresponding measured glucose
levels using an electrometer. RF signals may be used to transmit the
collected data. One aspect of certain analyte monitoring systems include
a transcutaneous or subcutaneous analyte sensor configuration which is,
for example, at least partially positioned through the skin layer of a
subject whose analyte level is to be monitored. The sensor may use a two
or three-electrode (work, reference and counter electrodes) configuration
driven by a controlled potential (potentiostat) analog circuit connected
through a contact system.

[0003] An analyte sensor may be configured so that a portion thereof is
placed under the skin of the patient so as to contact analyte of the
patient, and another portion or segment of the analyte sensor may be in
communication with the transmitter unit. The transmitter unit may be
configured to transmit the analyte levels detected by the sensor over a
wireless communication link such as an RF (radio frequency) communication
link to a receiver/monitor unit. The receiver/monitor unit may perform
data analysis, among other functions, on the received analyte levels to
generate information pertaining to the monitored analyte levels.

[0004] Transmission of data over an RF communication link is often
constrained to occur within a substantially short time duration. In turn,
the time constraint in RF data communication imposes limits on the type
and size of data that may be transmitted during the transmission time
period.

[0005] In view of the foregoing, it would be desirable to have a method
and apparatus for optimizing the RF communication link between two or
more communication devices, for example, in a medical communication
system.

SUMMARY OF THE INVENTION

[0006] Devices and methods for analyte monitoring, e.g., glucose
monitoring, are provided. Embodiments include transmitting information
from a first location to a second, e.g., using a telemetry system such as
RF telemetry. Systems herein include continuous analyte monitoring
systems and discrete analyte monitoring system.

[0007] In one embodiment, a method including retrieving a first data type,
retrieving a second data type, transmitting a first data packet including
the first data type and the second data type, updating the second data
type, and generating a second data packet including the first data type
and the updated second data type, is disclosed, as well as devices and
systems for the same.

[0008] These and other objects, features and advantages of the present
invention will become more fully apparent from the following detailed
description of the embodiments, the appended claims and the accompanying
drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] FIG. 1 illustrates a block diagram of a data monitoring and
management system for practicing one or more embodiments of the present
invention;

[0010]FIG. 2 is a block diagram of the transmitter unit of the data
monitoring and management system shown in FIG. 1 in accordance with one
embodiment of the present invention;

[0011] FIG. 3 is a block diagram of the receiver/monitor unit of the data
monitoring and management system shown in FIG. 1 in accordance with one
embodiment of the present invention;

[0012] FIG. 4 is a flowchart illustrating data packet procedure including
rolling data for transmission in accordance with one embodiment of the
present invention; and

[0013] FIG. 5 is a flowchart illustrating data processing of the received
data packet including the rolling data in accordance with one embodiment
of the present invention.

DETAILED DESCRIPTION

[0014] As summarized above and as described in further detail below, in
accordance with the various embodiments of the present invention, there
is provided a method and system for retrieving a first data type,
retrieving a second data type, transmitting a first data packet including
the first data type and the second data type, updating the second data
type, and generating a second data packet including the first data type
and the updated second data type.

[0015] FIG. 1 illustrates a data monitoring and management system such as,
for example, analyte (e.g., glucose) monitoring system 100 in accordance
with one embodiment of the present invention. The subject invention is
further described primarily with respect to a glucose monitoring system
for convenience and such description is in no way intended to limit the
scope of the invention. It is to be understood that the analyte
monitoring system may be configured to monitor a variety of analytes,
e.g., lactate, and the like.

[0016] Analytes that may be monitored include, for example, acetyl
choline, amylase, bilirubin, cholesterol, chorionic gonadotropin,
creatine kinase (e.g., CK-MB), creatine, DNA, fructosamine, glucose,
glutamine, growth hormones, hormones, ketones, lactate, peroxide,
prostate-specific antigen, prothrombin, RNA, thyroid stimulating hormone,
and troponin. The concentration of drugs, such as, for example,
antibiotics (e.g., gentamicin, vancomycin, and the like), digitoxin,
digoxin, drugs of abuse, theophylline, and warfarin, may also be
monitored. More than one analyte may be monitored by a single system,
e.g. a single analyte sensor.

[0017] The analyte monitoring system 100 includes a sensor unit 101, a
transmitter unit 102 coupleable to the sensor unit 101, and a primary
receiver unit 104 which is configured to communicate with the transmitter
unit 102 via a communication link 103. The primary receiver unit 104 may
be further configured to transmit data to a data processing terminal 105
for evaluating the data received by the primary receiver unit 104.
Moreover, the data processing terminal 105 in one embodiment may be
configured to receive data directly from the transmitter unit 102 via a
communication link 106 which may optionally be configured for
bi-directional communication. Accordingly, transmitter unit 102 and/or
receiver unit 104 may include a transceiver.

[0018] Also shown in FIG. 1 is an optional secondary receiver unit 106
which is operatively coupled to the communication link and configured to
receive data transmitted from the transmitter unit 102. Moreover, as
shown in the Figure, the secondary receiver unit 106 is configured to
communicate with the primary receiver unit 104 as well as the data
processing terminal 105. Indeed, the secondary receiver unit 106 may be
configured for bi-directional wireless communication with each or one of
the primary receiver unit 104 and the data processing terminal 105. As
discussed in further detail below, in one embodiment of the present
invention, the secondary receiver unit 106 may be configured to include a
limited number of functions and features as compared with the primary
receiver unit 104. As such, the secondary receiver unit 106 may be
configured substantially in a smaller compact housing or embodied in a
device such as a wrist watch, pager, mobile phone, PDA, for example.
Alternatively, the secondary receiver unit 106 may be configured with the
same or substantially similar functionality as the primary receiver unit
104. The receiver unit may be configured to be used in conjunction with a
docking cradle unit, for example for one or more of the following or
other functions: placement by bedside, for re-charging, for data
management, for night time monitoring, and/or bi-directional
communication device.

[0019] In one aspect sensor unit 101 may include two or more sensors, each
configured to communicate with transmitter unit 102. Furthermore, while
only one, transmitter unit 102, communication link 103, and data
processing terminal 105 are shown in the embodiment of the analyte
monitoring system 100 illustrated in FIG. 1. However, it will be
appreciated by one of ordinary skill in the art that the analyte
monitoring system 100 may include one or more sensors, multiple
transmitter units 102, communication links 103, and data processing
terminals 105. Moreover, within the scope of the present invention, the
analyte monitoring system 100 may be a continuous monitoring system, or
semi-continuous, or a discrete monitoring system. In a multi-component
environment, each device is configured to be uniquely identified by each
of the other devices in the system so that communication conflict is
readily resolved between the various components within the analyte
monitoring system 100.

[0020] In one embodiment of the present invention, the sensor unit 101 is
physically positioned in or on the body of a user whose analyte level is
being monitored. The sensor unit 101 may be configured to continuously
sample the analyte level of the user and convert the sampled analyte
level into a corresponding data signal for transmission by the
transmitter unit 102. In certain embodiments, the transmitter unit 102
may be physically coupled to the sensor unit 101 so that both devices are
integrated in a single housing and positioned on the user's body. The
transmitter unit 102 may perform data processing such as filtering and
encoding on data signals and/or other functions, each of which
corresponds to a sampled analyte level of the user, and in any event
transmitter unit 102 transmits analyte information to the primary
receiver unit 104 via the communication link 103.

[0021] In one embodiment, the analyte monitoring system 100 is configured
as a one-way RF communication path from the transmitter unit 102 to the
primary receiver unit 104. In such embodiment, the transmitter unit 102
transmits the sampled data signals received from the sensor unit 101
without acknowledgement from the primary receiver unit 104 that the
transmitted sampled data signals have been received. For example, the
transmitter unit 102 may be configured to transmit the encoded sampled
data signals at a fixed rate (e.g., at one minute intervals) after the
completion of the initial power on procedure. Likewise, the primary
receiver unit 104 may be configured to detect such transmitted encoded
sampled data signals at predetermined time intervals. Alternatively, the
analyte monitoring system 100 may be configured with a bi-directional RF
(or otherwise) communication between the transmitter unit 102 and the
primary receiver unit 104.

[0022] Additionally, in one aspect, the primary receiver unit 104 may
include two sections. The first section is an analog interface section
that is configured to communicate with the transmitter unit 102 via the
communication link 103. In one embodiment, the analog interface section
may include an RF receiver and an antenna for receiving and amplifying
the data signals from the transmitter unit 102, which are thereafter,
demodulated with a local oscillator and filtered through a band-pass
filter. The second section of the primary receiver unit 104 is a data
processing section which is configured to process the data signals
received from the transmitter unit 102 such as by performing data
decoding, error detection and correction, data clock generation, and data
bit recovery.

[0023] In operation, upon completing the power-on procedure, the primary
receiver unit 104 is configured to detect the presence of the transmitter
unit 102 within its range based on, for example, the strength of the
detected data signals received from the transmitter unit 102 and/or a
predetermined transmitter identification information. Upon successful
synchronization with the corresponding transmitter unit 102, the primary
receiver unit 104 is configured to begin receiving from the transmitter
unit 102 data signals corresponding to the user's detected analyte level.
More specifically, the primary receiver unit 104 in one embodiment is
configured to perform synchronized time hopping with the corresponding
synchronized transmitter unit 102 via the communication link 103 to
obtain the user's detected analyte level.

[0024] Referring again to FIG. 1, the data processing terminal 105 may
include a personal computer, a portable computer such as a laptop or a
handheld device (e.g., personal digital assistants (PDAs)), and the like,
each of which may be configured for data communication with the receiver
via a wired or a wireless connection. Additionally, the data processing
terminal 105 may further be connected to a data network (not shown) for
storing, retrieving and updating data corresponding to the detected
analyte level of the user.

[0025] Within the scope of the present invention, the data processing
terminal 105 may include an infusion device such as an insulin infusion
pump (external or implantable) or the like, which may be configured to
administer insulin to patients, and which may be configured to
communicate with the receiver unit 104 for receiving, among others, the
measured analyte level. Alternatively, the receiver unit 104 may be
configured to integrate or otherwise couple to an infusion device therein
so that the receiver unit 104 is configured to administer insulin therapy
to patients, for example, for administering and modifying basal profiles,
as well as for determining appropriate boluses for administration based
on, among others, the detected analyte levels received from the
transmitter unit 102.

[0026] Additionally, the transmitter unit 102, the primary receiver unit
104 and the data processing terminal 105 may each be configured for
bi-directional wireless communication such that each of the transmitter
unit 102, the primary receiver unit 104 and the data processing terminal
105 may be configured to communicate (that is, transmit data to and
receive data from) with each other via the wireless communication link
103. More specifically, the data processing terminal 105 may in one
embodiment be configured to receive data directly from the transmitter
unit 102 via the communication link 106, where the communication link
106, as described above, may be configured for bi-directional
communication.

[0027] In this embodiment, the data processing terminal 105 which may
include an insulin pump, may be configured to receive the analyte signals
from the transmitter unit 102, and thus, incorporate the functions of the
receiver 103 including data processing for managing the patient's insulin
therapy and analyte monitoring. In one embodiment, the communication link
103 may include one or more of an RF communication protocol, an infrared
communication protocol, a Bluetooth enabled communication protocol, an
802.11x wireless communication protocol, or an equivalent wireless
communication protocol which would allow secure, wireless communication
of several units (for example, per HIPPA requirements) while avoiding
potential data collision and interference.

[0028]FIG. 2 is a block diagram of the transmitter of the data monitoring
and detection system shown in FIG. 1 in accordance with one embodiment of
the present invention. Referring to the Figure, the transmitter unit 102
in one embodiment includes an analog interface 201 configured to
communicate with the sensor unit 101 (FIG. 1), a user input 202, and a
temperature measurement section 203, each of which is operatively coupled
to a transmitter processor 204 such as a central processing unit (CPU).
As can be seen from FIG. 2, there are provided four contacts, three of
which are electrodes--work electrode (W) 210, guard contact (G) 211,
reference electrode (R) 212, and counter electrode (C) 213, each
operatively coupled to the analog interface 201 of the transmitter unit
102 for connection to the sensor unit 101 (FIG. 1). In one embodiment,
each of the work electrode (W) 210, guard contact (G) 211, reference
electrode (R) 212, and counter electrode (C) 213 may be made using a
conductive material that is either printed or etched or ablated, for
example, such as carbon which may be printed, or a metal such as a metal
foil (e.g., gold) or the like, which may be etched or ablated or
otherwise processed to provide one or more electrodes. Fewer or greater
electrodes and/or contact may be provided in certain embodiments.

[0029] Further shown in FIG. 2 are a transmitter serial communication
section 205 and an RF transmitter 206, each of which is also operatively
coupled to the transmitter processor 204. Moreover, a power supply 207
such as a battery is also provided in the transmitter unit 102 to provide
the necessary power for the transmitter unit 102. Additionally, as can be
seen from the Figure, clock 208 is provided to, among others, supply real
time information to the transmitter processor 204.

[0030] In one embodiment, a unidirectional input path is established from
the sensor unit 101 (FIG. 1) and/or manufacturing and testing equipment
to the analog interface 201 of the transmitter unit 102, while a
unidirectional output is established from the output of the RF
transmitter 206 of the transmitter unit 102 for transmission to the
primary receiver unit 104. In this manner, a data path is shown in FIG. 2
between the aforementioned unidirectional input and output via a
dedicated link 209 from the analog interface 201 to serial communication
section 205, thereafter to the processor 204, and then to the RF
transmitter 206. As such, in one embodiment, via the data path described
above, the transmitter unit 102 is configured to transmit to the primary
receiver unit 104 (FIG. 1), via the communication link 103 (FIG. 1),
processed and encoded data signals received from the sensor unit 101
(FIG. 1). Additionally, the unidirectional communication data path
between the analog interface 201 and the RF transmitter 206 discussed
above allows for the configuration of the transmitter unit 102 for
operation upon completion of the manufacturing process as well as for
direct communication for diagnostic and testing purposes.

[0031] As discussed above, the transmitter processor 204 is configured to
transmit control signals to the various sections of the transmitter unit
102 during the operation of the transmitter unit 102. In one embodiment,
the transmitter processor 204 also includes a memory (not shown) for
storing data such as the identification information for the transmitter
unit 102, as well as the data signals received from the sensor unit 101.
The stored information may be retrieved and processed for transmission to
the primary receiver unit 104 under the control of the transmitter
processor 204. Furthermore, the power supply 207 may include a
commercially available battery, which may be a rechargeable battery.

[0032] In certain embodiments, the transmitter unit 102 is also configured
such that the power supply section 207 is capable of providing power to
the transmitter for a minimum of about three months of continuous
operation, e.g., after having been stored for about eighteen months such
as stored in a low-power (non-operating) mode. In one embodiment, this
may be achieved by the transmitter processor 204 operating in low power
modes in the non-operating state, for example, drawing no more than
approximately 1 μA of current. Indeed, in one embodiment, a step
during the manufacturing process of the transmitter unit 102 may place
the transmitter unit 102 in the lower power, non-operating state (i.e.,
post-manufacture sleep mode). In this manner, the shelf life of the
transmitter unit 102 may be significantly improved. Moreover, as shown in
FIG. 2, while the power supply unit 207 is shown as coupled to the
processor 204, and as such, the processor 204 is configured to provide
control of the power supply unit 207, it should be noted that within the
scope of the present invention, the power supply unit 207 is configured
to provide the necessary power to each of the components of the
transmitter unit 102 shown in FIG. 2.

[0033] Referring back to FIG. 2, the power supply section 207 of the
transmitter unit 102 in one embodiment may include a rechargeable battery
unit that may be recharged by a separate power supply recharging unit
(for example, provided in the receiver unit 104) so that the transmitter
unit 102 may be powered for a longer period of usage time. Moreover, in
one embodiment, the transmitter unit 102 may be configured without a
battery in the power supply section 207, in which case the transmitter
unit 102 may be configured to receive power from an external power supply
source (for example, a battery) as discussed in further detail below.

[0034] Referring yet again to FIG. 2, the temperature measurement section
203 of the transmitter unit 102 is configured to monitor the temperature
of the skin near the sensor insertion site. The temperature reading is
used to adjust the analyte readings obtained from the analog interface
201. In certain embodiments, the RF transmitter 206 of the transmitter
unit 102 may be configured for operation in the frequency band of 315 MHz
to 322 MHz, for example, in the United States. Further, in one
embodiment, the RF transmitter 206 is configured to modulate the carrier
frequency by performing Frequency Shift Keying and Manchester encoding.
In one embodiment, the data transmission rate is about 19,200 symbols per
second, with a minimum transmission range for communication with the
primary receiver unit 104.

[0035] Referring yet again to FIG. 2, also shown is a leak detection
circuit 214 coupled to the guard electrode (G) 211 and the processor 204
in the transmitter unit 102 of the data monitoring and management system
100. The leak detection circuit 214 in accordance with one embodiment of
the present invention may be configured to detect leakage current in the
sensor unit 101 to determine whether the measured sensor data are corrupt
or whether the measured data from the sensor 101 is accurate.

[0036] Description of sensor, calibration (singlepoint), and/or exemplary
analyte systems that may be employed are described in, for example, U.S.
Pat. Nos. 6,134,461, 6,175,752, 6,121,611, 6,560,471, 6,746,582, and
elsewhere.

[0037] FIG. 3 is a block diagram of the receiver/monitor unit of the data
monitoring and management system shown in FIG. 1 in accordance with one
embodiment of the present invention. Referring to FIG. 3, the primary
receiver unit 104 includes an analyte test strip, e.g., blood glucose
test strip, interface 301, an RF receiver 302, an input 303, a
temperature monitor section 304, and a clock 305, each of which is
operatively coupled to a receiver processor 307. As can be further seen
from the Figure, the primary receiver unit 104 also includes a power
supply 306 operatively coupled to a power conversion and monitoring
section 308. Further, the power conversion and monitoring section 308 is
also coupled to the receiver processor 307. Moreover, also shown are a
receiver serial communication section 309, and an output 310, each
operatively coupled to the receiver processor 307.

[0038] In one embodiment, the test strip interface 301 includes a glucose
level testing portion to receive a manual insertion of a glucose test
strip, and thereby determine and display the glucose level of the test
strip on the output 310 of the primary receiver unit 104. This manual
testing of glucose may be used to calibrate the sensor unit 101 (FIG. 1)
or otherwise. The RF receiver 302 is configured to communicate, via the
communication link 103 (FIG. 1) with the RF transmitter 206 of the
transmitter unit 102, to receive encoded data signals from the
transmitter unit 102 for, among others, signal mixing, demodulation, and
other data processing. The input 303 of the primary receiver unit 104 is
configured to allow the user to enter information into the primary
receiver unit 104 as needed. In one aspect, the input 303 may include one
or more keys of a keypad, a touch-sensitive screen, or a voice-activated
input command unit. The temperature monitor section 304 is configured to
provide temperature information of the primary receiver unit 104 to the
receiver processor 307, while the clock 305 provides, among others, real
time information to the receiver processor 307.

[0039] Each of the various components of the primary receiver unit 104
shown in FIG. 3 is powered by the power supply 306 which, in one
embodiment, includes a battery. Furthermore, the power conversion and
monitoring section 308 is configured to monitor the power usage by the
various components in the primary receiver unit 104 for effective power
management and to alert the user, for example, in the event of power
usage which renders the primary receiver unit 104 in sub-optimal
operating conditions. An example of such sub-optimal operating condition
may include, for example, operating the vibration output mode (as
discussed below) for a period of time thus substantially draining the
power supply 306 while the processor 307 (thus, the primary receiver unit
104) is turned on. Moreover, the power conversion and monitoring section
308 may additionally be configured to include a reverse polarity
protection circuit such as a field effect transistor (FET) configured as
a battery activated switch.

[0040] The serial communication section 309 in the primary receiver unit
104 is configured to provide a bi-directional communication path from the
testing and/or manufacturing equipment for, among others, initialization,
testing, and configuration of the primary receiver unit 104. Serial
communication section 309 can also be used to upload data to a computer,
such as time-stamped blood glucose data. The communication link with an
external device (not shown) can be made, for example, by cable, infrared
(IR) or RF link. The output 310 of the primary receiver unit 104 is
configured to provide, among others, a graphical user interface (GUI)
such as a liquid crystal display (LCD) for displaying information.
Additionally, the output 310 may also include an integrated speaker for
outputting audible signals as well as to provide vibration output as
commonly found in handheld electronic devices, such as mobile telephones
presently available. In a further embodiment, the primary receiver unit
104 also includes an electro-luminescent lamp configured to provide
backlighting to the output 310 for output visual display in dark ambient
surroundings.

[0041] Referring back to FIG. 3, the primary receiver unit 104 in one
embodiment may also include a storage section such as a programmable,
non-volatile memory device as part of the processor 307, or provided
separately in the primary receiver unit 104, operatively coupled to the
processor 307. The processor 307 may be configured to synchronize with a
transmitter, e.g., using Manchester decoding or the like, as well as
error detection and correction upon the encoded data signals received
from the transmitter unit 102 via the communication link 103.

[0042] Additional description of the RF communication between the
transmitter 102 and the primary receiver 104 (or with the secondary
receiver 106) that may be employed in embodiments of the subject
invention is disclosed in pending application Ser. No. 11/060,365 filed
Feb. 16, 2005 entitled "Method and System for Providing Data
Communication in Continuous Glucose Monitoring and Management System" the
disclosure of which is incorporated herein by reference for all purposes.

[0043] Referring to the Figures, in one embodiment, the transmitter 102
(FIG. 1) may be configured to generate data packets for periodic
transmission to one or more of the receiver units 104, 106, where each
data packet includes in one embodiment two categories of data--urgent
data and non-urgent data. For example, urgent data such as for example
glucose data from the sensor and/or temperature data associated with the
sensor may be packed in each data packet in addition to non-urgent data,
where the non-urgent data is rolled or varied with each data packet
transmission.

[0044] That is, the non-urgent data is transmitted at a timed interval so
as to maintain the integrity of the analyte monitoring system without
being transmitted over the RF communication link with each data
transmission packet from the transmitter 102. In this manner, the
non-urgent data, for example that are not time sensitive, may be
periodically transmitted (and not with each data packet transmission) or
broken up into predetermined number of segments and sent or transmitted
over multiple packets, while the urgent data is transmitted substantially
in its entirety with each data transmission.

[0045] Referring again to the Figures, upon receiving the data packets
from the transmitter 102, the one or more receiver units 104, 106 may be
configured to parse the received the data packet to separate the urgent
data from the non-urgent data, and also, may be configured to store the
urgent data and the non-urgent data, e.g., in a hierarchical manner. In
accordance with the particular configuration of the data packet or the
data transmission protocol, more or less data may be transmitted as part
of the urgent data, or the non-urgent rolling data. That is, within the
scope of the present disclosure, the specific data packet implementation
such as the number of bits per packet, and the like, may vary based on,
among others, the communication protocol, data transmission time window,
and so on.

[0046] In an exemplary embodiment, different types of data packets may be
identified accordingly. For example, identification in certain exemplary
embodiments may include--(1) single sensor, one minute of data, (2) two
or multiple sensors, (3) dual sensor, alternate one minute data, and (4)
response packet. For single sensor one minute data packet, in one
embodiment, the transmitter 102 may be configured to generate the data
packet in the manner, or similar to the manner, shown in Table 1 below.

[0047] As shown in Table 1 above, the transmitter data packet in one
embodiment may include 8 bits of transmit time data, 14 bits of current
sensor data, 14 bits of preceding sensor data, 8 bits of transmitter
status data, 12 bits of auxiliary counter data, 12 bits of auxiliary
thermistor 1 data, 12 bits of auxiliary thermistor 1 data and 8 bits of
rolling data. In one embodiment of the present invention, the data packet
generated by the transmitter for transmission over the RF communication
link may include all or some of the data shown above in Table 1.

[0048] Referring back, the 14 bits of the current sensor data provides the
real time or current sensor data associated with the detected analyte
level, while the 14 bits of the sensor historic or preceding sensor data
includes the sensor data associated with the detected analyte level one
minute ago. In this manner, in the case where the receiver unit 104, 106
drops or fails to successfully receive the data packet from the
transmitter 102 in the minute by minute transmission, the receiver unit
104, 106 may be able to capture the sensor data of a prior minute
transmission from a subsequent minute transmission.

[0049] Referring again to Table 1, the Auxiliary data in one embodiment
may include one or more of the patient's skin temperature data, a
temperature gradient data, reference data, and counter electrode voltage.
The transmitter status field may include status data that is configured
to indicate corrupt data for the current transmission (for example, if
shown as BAD status (as opposed to GOOD status which indicates that the
data in the current transmission is not corrupt)). Furthermore, the
rolling data field is configured to include the non-urgent data, and in
one embodiment, may be associated with the time-hop sequence number. In
addition, the Transmitter Time field in one embodiment includes a
protocol value that is configured to start at zero and is incremented by
one with each data packet. In one aspect, the transmitter time data may
be used to synchronize the data transmission window with the receiver
unit 104, 106, and also, provide an index for the Rolling data field.

[0050] In a further embodiment, the transmitter data packet may be
configured to provide or transmit analyte sensor data from two or more
independent analyte sensors. The sensors may relate to the same or
different analyte or property. In such a case, the data packet from the
transmitter 102 may be configured to include 14 bits of the current
sensor data from both sensors in the embodiment in which 2 sensors are
employed. In this case, the data packet does not include the immediately
preceding sensor data in the current data packet transmission. Instead, a
second analyte sensor data is transmitted with a first analyte sensor
data.

[0051] In a further embodiment, the transmitter data packet may be
alternated with each transmission between two analyte sensors, for
example, alternating between the data packet shown in Table 3 and Table 4
below.

[0052] As shown above in reference to Tables 3 and 4, the minute by minute
data packet transmission from the transmitter 102 (FIG. 1) in one
embodiment may alternate between the data packet shown in Table 3 and the
data packet shown in Table 4. More specifically, the transmitter 102 may
be configured in one embodiment transmit the current sensor data of the
first sensor and the preceding sensor data of the first sensor (Table 3),
as well as the rolling data, and further, at the subsequent transmission,
the transmitter 102 may be configured to transmit the current sensor data
of the first and the second sensor in addition to the rolling data.

[0053] In one embodiment, the rolling data transmitted with each data
packet may include a sequence of various predetermined types of data that
are considered not-urgent or not time sensitive. That is, in one
embodiment, the following list of data shown in Table 6 may be
sequentially included in the 8 bits of transmitter data packet, and not
transmitted with each data packet transmission of the transmitter (for
example, with each 60 second data transmission from the transmitter 102).

[0054] As can be seen from Table 6 above, in one embodiment, a sequence of
rolling data are appended or added to the transmitter data packet with
each data transmission time slot. In one embodiment, there may be 256
time slots for data transmission by the transmitter 102 (FIG. 1), and
where, each time slot is separately by approximately 60 second interval.
For example, referring to the Table 6 above, the data packet in
transmission time slot 0 (zero) may include operational mode data (Mode)
as the rolling data that is appended to the transmitted data packet. At
the subsequent data transmission time slot (for example, approximately 60
seconds after the initial time slot (0), the transmitted data packet may
include the analyte sensor 1 calibration factor information (Glucose1
slope) as the rolling data. In this manner, with each data transmission,
the rolling data may be updated over the 256 time slot cycle.

[0055] Referring again to Table 6, each rolling data field is described in
further detail for various embodiments. For example, the Mode data may
include information related to the different operating modes such as, but
not limited to, the data packet type, the type of battery used,
diagnostic routines, single sensor or multiple sensor input, type of data
transmission (rf communication link or other data link such as serial
connection). Further, the Glucose1-slope data may include an 8-bit
scaling factor or calibration data for first sensor (scaling factor for
sensor 1 data), while Glucose2-slope data may include an 8-bit scaling
factor or calibration data for the second analyte sensor (in the
embodiment including more than one analyte sensors).

[0056] In addition, the Ref-R data may include 12 bits of on-board
reference resistor used to calibrate our temperature measurement in the
thermistor circuit (where 8 bits are transmitted in time slot 3, and the
remaining 4 bits are transmitted in time slot 4), and the 20-bit Hobbs
counter data may be separately transmitted in three time slots (for
example, in time slot 4, time slot 5 and time slot 6) to add up to 20
bits. In one embodiment, the Hobbs counter may be configured to count
each occurrence of the data transmission (for example, a packet
transmission at approximately 60 second intervals) and may be incremented
by a count of one (1).

[0057] In one aspect, the Hobbs counter is stored in a nonvolatile memory
of the transmitter unit 102 (FIG. 1) and may be used to ascertain the
power supply status information such as, for example, the estimated
battery life remaining in the transmitter unit 102. That is, with each
sensor replacement, the Hobbs counter is not reset, but rather, continues
the count with each replacement of the sensor unit 101 to establish
contact with the transmitter unit 102 such that, over an extended usage
time period of the transmitter unit 102, it may be possible to determine,
based on the Hobbs count information, the amount of consumed battery life
in the transmitter unit 102, and also, an estimated remaining life of the
battery in the transmitter unit 102.

[0058] FIG. 4 is a flowchart illustrating a data packet procedure
including rolling data for transmission in accordance with one embodiment
of the present invention. Referring to FIG. 4, in one embodiment, a
counter is initialized (for example, to T=0) (410). Thereafter the
associated rolling data is retrieved from memory device, for example
(420), and also, the time sensitive or urgent data is retrieved (430). In
one embodiment, the retrieval of the rolling data (420) and the retrieval
of the time sensitive data (430) may be retrieved at substantially the
same time.

[0059] Referring back to FIG. 4, with the rolling data and the time
sensitive data, for example, the data packet for transmission is
generated (440), an upon transmission, the counter is incremented by one
(430) and the routine returns to retrieval of the rolling data (420). In
this manner, in one embodiment, the urgent time sensitive data as well as
the non-urgent data may be incorporated in the same data packet and
transmitted by the transmitter 102 (FIG. 1) to a remote device such as
one or more of the receivers 104, 106. Furthermore, as discussed above,
the rolling data may be updated at a predetermined time interval which is
longer than the time interval for each data packet transmission from the
transmitter 102 (FIG. 1).

[0060] FIG. 5 is a flowchart illustrating data processing of the received
data packet including the rolling data in accordance with one embodiment
of the present invention. Referring to FIG. 5, when the data packet is
received (510) (for example, by one or more of the receivers 104, 106, in
one embodiment. the received data packet is parsed so that the urgent
data may be separated from the not-urgent data (520) (stored in, for
example, the rolling data field in the data packet). Thereafter the
parsed data is suitably stored in an appropriate memory or storage device
(530).

[0061] In the manner described above, in accordance with one embodiment of
the present invention, there is provided method and apparatus for
separating non-urgent type data (for example, data associated with
calibration) from urgent type data (for example, monitored analyte
related data) to be transmitted over the communication link to minimize
the potential burden or constraint on the available transmission time.
More specifically, in one embodiment, non-urgent data may be separated
from data that is required by the communication system to be transmitted
immediately, and transmitted over the communication link together while
maintaining a minimum transmission time window. In one embodiment, the
non-urgent data may be parsed or broken up in to a number of data
segments, and transmitted over multiple data packets. The time sensitive
immediate data (for example, the analyte sensor data, temperature data
etc), may be transmitted over the communication link substantially in its
entirety with each data packet or transmission.

[0062] Accordingly, in one embodiment, there is provided a method
including retrieving a first data type, retrieving a second data type,
transmitting a first data packet including the first data type and the
second data type, updating the second data type, and generating a second
data packet including the first data type and the updated second data
type.

[0063] In one aspect, the first data type may be associated with urgent
data, and further, where the second data type may be associated with
non-urgent data.

[0064] In another aspect, the first data type may include real time
analyte data associated with the monitored analyte level of a patient,
and further, where the analyte may include glucose. Moreover, in one
aspect, the first data type may be related to glucose level information,
and the second data type may be related to a predetermined scaling factor
associated with the glucose level information.

[0065] In still another aspect, the second data type may include one or
more of a component status information, a calibration data, or an analyte
sensor count information.

[0066] Moreover, the second data type and the updated second data type may
be different.

[0067] The method may also include encrypting the first data packet before
transmission. Moreover, the method may also include encrypting the second
data packet.

[0068] Furthermore, in still another aspect, the method may include
transmitting the encrypted second data packet, where the first data
packet transmission and the second data packet transmission may be
separated by one of approximately 60 seconds, less than five minutes,
five minutes, or greater than five minutes.

[0069] Additionally, each of the first and second data packets may include
a transmit time count which is incremented by an integer value with each
subsequent transmission.

[0070] A method in accordance with another embodiment may include
receiving a data packet, parsing the received data packet such that a
first data type and a second data type are retrieved from the received
data packet, and wherein the first data type is urgent type data, and the
second data type is non-urgent type data.

[0071] The urgent type data in one embodiment may include analyte sensor
data, and further, where the analyte may include glucose. Moreover, in
one aspect, the first data type may be related to glucose level
information, and the second data type may be related to a predetermined
scaling factor associated with the glucose level information.

[0072] The method may further include storing the first data type and the
second data type.

[0073] An apparatus in accordance with another embodiment of the present
invention includes one or more processing units, and a memory for storing
instructions which, when executed by the one or more processors, causes
the one or more processing units to retrieve a first data type, retrieve
a second data type, transmit a first data packet including the first data
type and the second data type, update the second data type, and generate
a second data packet including the first data type and the updated second
data type.

[0074] In another aspect, the apparatus may also include an rf transmitter
coupled to be one or more processing units, and configured to transmit
the first data packet, and the second data packet.

[0075] In still another aspect, the apparatus may include a medical module
operatively coupled to the one or more processing units and the memory.

[0076] The medical module may include a continuous glucose monitoring
device.

[0077] Furthermore, there may be provided a housing, where the medical
module, the one or more processing units and the memory are integrated
substantially within the housing.

[0078] The various processes described above including the processes
performed by the processor 204 in the software application execution
environment in the transmitter 102 as well as any other suitable or
similar processing units embodied in the analyte monitoring system 100
including the processes and routines described in conjunction with FIGS.
4-5, may be embodied as computer programs developed using an object
oriented language that allows the modeling of complex systems with
modular objects to create abstractions that are representative of real
world, physical objects and their interrelationships. The software
required to carry out the inventive process, which may be stored in a
memory or storage unit (not shown) of the processor 204 or the
transmitter 102, may be developed by a person of ordinary skill in the
art and may include one or more computer program products.

[0079] Various other modifications and alterations in the structure and
method of operation of this invention will be apparent to those skilled
in the art without departing from the scope and spirit of the invention.
Although the invention has been described in connection with specific
preferred embodiments, it should be understood that the invention as
claimed should not be unduly limited to such specific embodiments. It is
intended that the following claims define the scope of the present
invention and that structures and methods within the scope of these
claims and their equivalents be covered thereby.